Cleanroom System Case Study: ISO Class 7 Pharmaceutical Facility — Design to Completion
This case study documents a completed cleanroom project supplied by Aqua Route for a pharmaceutical tablet manufacturing facility. The facility required an ISO Class 7 (Class 10,000) cleanroom environment across approximately 800 square meters of production and packaging space. The project involved full modular cleanroom panel systems, airtight door assemblies, and coordination with the client’s HVAC and MEP contractors.
Project Background
The client was a mid-sized pharmaceutical manufacturer expanding production capacity at their existing factory. The new cleanroom zone needed to meet ISO 14644-1 Class 7 standards for particulate contamination, with a secondary requirement for smooth, chemical-resistant internal surfaces suitable for daily cleaning with industrial disinfectants.
The project timeline from order confirmation to installation completion was 11 weeks — including 3 weeks for technical drawing approval, 5 weeks for production, and 3 weeks for on-site installation.
Panel System Specified
Aqua Route supplied 50mm PIR-core cleanroom panels with a 0.5mm pre-painted galvanized steel facing in white RAL9010. The panel joints used a tongue-and-groove interlocking system with continuous airtight sealing — a critical detail for maintaining the positive pressure differential required in ISO Class 7 environments. All panel edges were finished with aluminum trim profiles to eliminate crevices where particulates could accumulate.
PIR core was specified over standard PU for two reasons: the client’s local fire authority required Class B fire-rated wall and ceiling panels for any room attached to a pharmaceutical production line, and the PIR surface offers marginally better chemical resistance to the cleaning agents used in the facility.
Door Assemblies
Three airtight sliding door assemblies were supplied for the main cleanroom entrances. Each door featured a full perimeter inflatable gasket seal, ensuring zero air bypass when closed. The door frames were flush with the panel surface — no exposed channels or lips — to comply with GMP (Good Manufacturing Practice) requirements for cleanable surfaces. Electric actuators were specified for the sliding mechanism to allow hands-free operation by gowned personnel.
One additional swing door was supplied for an emergency exit, fitted with a door closer and panic bar, also with airtight sealing.
HVAC Coordination
Aqua Route’s technical team provided ceiling panel layouts with pre-cut openings for HVAC supply diffusers and return air grilles, coordinated directly with the client’s mechanical contractor. Cleanroom HVAC design was outside Aqua Route’s scope, but the panel system was designed to accommodate 12 air changes per hour — the minimum recommended for ISO Class 7 — with penetration sleeves provided for all ductwork entries.
Installation Process
The installation team worked in three phases. First, floor-mounted base channels were installed and leveled across the entire cleanroom perimeter and all internal partition lines. Second, wall panels were assembled from floor to ceiling using the interlocking joint system, with silicone sealant applied to every joint face before panel engagement. Third, ceiling panels were installed on a suspended grid system with adjustable hangers to account for the existing factory structure above.
Total installation time was 18 working days for a four-person team.
Certification Outcome
Following installation, the client’s independent validation contractor conducted particle count testing in accordance with ISO 14644-1. The facility achieved ISO Class 7 certification on first test — with measured particle counts at 0.5 micron significantly below the Class 7 limit of 352,000 particles per cubic meter.
The client noted that the airtight joint system and flush door frames were key factors in achieving certification without any remedial work.
Key Takeaways
Cleanroom projects require significantly more precision in both panel fabrication and installation than standard cold storage or industrial enclosures. Airtight sealing at every joint, flush surface detailing, and correct door specification are not optional — they are what determines whether the facility passes certification. Choosing a supplier who provides technical drawings, installation supervision, and direct factory communication makes the difference between a first-pass certification and expensive remedial work.